Roflumilast Topical Cream (ROFLUMILAST - TOPICAL)

For psoriasis.

Brand Name(s): Zoryve

Generic Name: Roflumilast

Instructions

DO NOT take this medicine by mouth.

Apply a thin layer to the affected area and rub it in.

Keep the medicine at room temperature. Avoid heat and direct light.

This medicine should only be used on the skin.

This medicine may be harmful if swallowed.

Avoid getting the medicine in the eyes, nose, or mouth. Wash the medicine off your fingers after applying it.

Avoid getting this medicine inside the vagina.

Wash your hands before and after handling this medicine.

Wash your hands after using this medicine unless your hands are part of the area being treated.

Do not touch your eyes, nose or mouth after handling the medicine.

If medicine gets in eyes, rinse with large amounts of cool water and seek medical care right away.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Do not use the medication any more than instructed.

It is unknown if this medicine passes into breast milk. Ask your doctor before breastfeeding.

During pregnancy, this medicine should be used only when clearly needed. Talk to your doctor about the risks and benefits.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you miss a dose, use it as soon as possible. If it is near the next diaper change, skip the missed dose. Do not double the dose.

Do not share this medicine with anyone who has not been prescribed this medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • diarrhea
  • headaches
  • nausea
  • skin irritation where medicine is applied

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • agitated feeling or trouble sleeping
  • fever or chills
  • signs of skin infection (such as irritation, redness, or swelling that does not improve)

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.

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